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Understanding ISO 9000 and Implementing the Basics to Quality
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This work examines the evolution and rationale of the ISO 9000 series of standards, their structure, interpretation and relationship to other quality systems. Theory and applications are provided, and the author explains how to put the standards into place and achieve quality. Specific methods and tools for the implementation of the ISO standards that lead to certification and certification maintenance are supplied.
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1
A General Introduction to Quality Standards
In this chapter our aim is to address the issue of quality standards and to demonstrate that the concept is not new, by summarizing some of the historical facts on quality. We will show that standards and certification procedures have been around for a long time. However, the difference between the early period and our modern time is that the process to certification is now more sophisticated and can be replicated on a more consistent basis.
In addition, we will provide an overview introduction to the standards of the International Standards Organization (ISO) and discuss the need for such standards not only in the European Union, but also in the United States and world markets.
As defined by ISO 8492 (BS 4778), quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. However, whose needs does the service or product address? Who are its customers? How do we define these needs? The questions are not easy to answer. In fact, the ISO has added seven footnotes to its definition, including: in a contractual environment, needs are specified, whereas in other environments, implied needs should be identified and defined and needs can change with time.
Within this definition we can identify ideas of fitness for purpose, value for money, reliability, customer satisfaction, environmental impact, versatility, compatibility with other products, maintainability, conformance to requirements, or other desired characteristics. These concepts of quality are not new, nor are they restricted to any age or culture.
In the laws of the kingdom of Eshunnanaāabout 2000 b.c.āwe find requirements dealing with interest rates, type of investments, and penalties (Goetz, 1973). In Hammurabiās codeāabout 1730 b.c.āwe find penalties for malfeasance (Meek, 1973).
In the days of the Egyptian pharaohs there was an extensively documented quality system relating to the burial of the nobility (Durant, 1954). This was known as the Book of the Dead. It described the manner in which the requisite rituals should be carried out and specified how the funerary goods to be buried with the deceased should be prepared. The purpose of this system was to ensure that the deceased enjoyed an afterlife that was at least with his or her life on earth.
Achievement of the required standard was attested to by the application of the mark of the Superintendent of the Necropolis. In the case of Tutankhamen, we find what is probably the worldās oldest and most famous quality failure. He was buried in a hurry, and the marks on two of the beds used in the embalming process show that the horizontal members were transposedāa situation that has parallels in modern industry.
The first Emperor of China, Qin Shi Huangdi, who was responsible for the vast, underground, terra-cotta army at Mount Li, decreed that all goods supplied for use in the imperial household should carry a mark that identified the maker so that if an item proved faulty he could be identified and punished (Durant, 1954). This was, indeed, a form of third-party certification.
In the Roman era we find for a first time that the external audit is instituted and specialists known as Argenteriiādealers in silverāwere required to keep certain records (Corns, 1968). On the other hand, the Bible gives us the byword of quality systems: āAn ounce of prevention is worth a pound of cure.ā
During the Byzantine Empire we find that every action was regulated by procedures that had to be followed to the letter. To enforce these procedures, the local governor had attached to his court retinue an official inspector, a Logothete, who was charged with the inspection of all workshops and operations performed in the district. If such an inspection disclosed an infraction of the rules, the Logothete would have the culprit brought to trial (Guerdan, 1956).
In large, stone European buildings, stones can be found that have the registered marks of the quality of goods produced by their members. The mark serves as a reminder that the Master Mason approved the work. Furthermore, the mark was a point of reference to the exact location and was useful for payment purposes (Allcock and Unsworth, 1991).
A similar situation existed with the merchant guilds. The products produced by their members were held to a much higher standard than everyone elseās goods. In fact, it is said that the merchants who bought cloth that bore the mark of the Colchester guild rarely troubled to open the bales because the mark of the Colchester guild was so powerful that it guaranteed a certain level of quality. Given that mark, the quality of the product was expected (Allcock and Unsworth, 1991).
In 1140, a system of hallmarking was introduced to bear witness to the quality of gold and silver items. Except for changes in the duty mark, this has remained unchanged to the present day.
Defense and quality have always been close partners and two British literary figures were prominent in establishing quality requirements in the defense industry of their age.
Geoffery Chaucer, as part of a varied military and diplomatic career in the last half of the 1300s, was Surveyor of Supplies for the Royal Wardrobe. In this role, he was a supply assessor and visited makers of armor, swords, saddles, and other equipment to establish suitability for the Royal Armory (Johnson and Green, 1993).
About 300 years later Samuel Pepys, as one of his many appointments associated with the navy, was the Surveyor-General of the Victualling Office where he proved himself an energetic and zealous reformer of abuses intended to sell the Admiralty short, by ensuring him that the goods to be supplied to the ships were of the requisite quality before they were purchased (Johnson and Green, 1993).
It was during World War I that quality took to the air and led the Royal Aircraft Establishment to try to improve the reliability of British engines. When an enemy engine failed, the prevailing wind usually allowed the pilot to return behind his own lines to fight another day, whereas the Allied pilot forced into the same action finished the war as a prisoner.
After the Armistice, there was a significant change in the scale and diversity of industry in general. Companies evolved from small, self-contained units into integrated operations where individuals no longer had total control over the end product. Individuals were now responsible for a specific part, which would then be passed from operator to operator or firm to firm, gathering other components on the way to completion.
This change was the introduction of inspectors who, independent of the manufacturing operations, would assess the work and return anything that was defective for rectification. Rework and reinspection were here to stay.
For many years this iterative process of make, inspect, accept, or rework has been the basis of the manufacturing industry. It is only recently that the more efficient and cost-effective concept of getting it right the first timeāevery time has started to replace it.
The further expansion in industrial and technological change, which was attendant on World War II, saw an increase in complexity in the manufacturing process and its products.
The first attempt to standardize quality was in the United States of America (USA) where expansion and its effects were greatest and the most significant. This standardization gave rise to MIL-Q-9858, which is a quality system specification, and MIL-I-45208 which specifies inspection system requirements (Mil Spec, 1956). Both standards are still current and are utilized in American defense contracts and elsewhere (Duncan, 1986).
These two standards formed the basis for a series of standards designed for use within the North Atlantic Treaty Organization (NATO). These were called the Allied Quality Assurance Publications (AQAP) 1, 4, and 9. AQAP-1 was a quality system specification and AQAP-4 and -9 were inspection system specifications. The former covered manufacturing, inspection, and testing, and the latter covered final inspection only (Levy, 1993).
Despite its membership in NATO, the United Kingdom did not accept the AQAP. Instead it introduced a series of three similar specifications called Defense Standards (DEF. STAN.).
The most significant difference between the DEF. STAN. and the AQAP was the introduction of some requirements for design to the quality system specification DEF. STAN. 05ā21, which otherwise compared with AQAP 1. The other two DEF. STAN. 05ā24 and 05ā29, were inspection system standards and covered the same subject matter as AQAP 4 and 9, respectively (Breitenberg, 1993).
The Ministry of Defence would assess companies engaged in defense contracts or which were subcontractors to defense contractors, and those found compliant with the requirements of the appropriate DEF. STAN. were registered. In theory, only registered firms could be used for defense contracts. This is an example of second-party assessment, because only two parties, the company and the Ministry, were involved and approval only indicated fitness to meet Ministry of Defence requirements.
At a later date the AQAP were aligned with the DEF. STAN. and progressively Ministry of Defence assessments have been aligned with AQAP standards. The DEF. STAN. are now obsolete.
The AQAP are very militaristic in their content and wording and make considerable use of that misunderstood word materiel on which many quality managersā reputations for literacy has foundered. In fact, it is a perfectly proper word, which was introduced in France during the Napoleonic Wars to indicate everything necessary to fight a battle or wage a war except the men and horses. By extension materiel now means everything needed to run a business except the personnel.
Within industry at large there was also a need for quality standards to work. Early attempts to meet...
Table of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Dedication
- About the Series
- Preface
- Table of Contents
- 1. A General Introduel ion to Quality Standards
- 2. Quality Vocabulary
- 3. Quality System Requirements
- 4. Third-Party Assessments
- 5. Implementation Strategy for ISO
- 6. Documentation Overview
- 7. ISO and Services
- 8. ISO and Software
- 9. ISO and BS 7750
- 10. ISO and Other Quality Systems
- 11. The Future of the ISO
- Appendix A. Unofficial Glossary of Acronyms
- Appendix B. Critical Characteristics for Procedures
- Appendix C. Training Curriculum
- Appendix D. General Information and Publications
- Selected Bibliography
- Index